Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices 36921

Devices Panel (did not include a closed

session); Dental Products Panel; Ear,

Nose, and Throat Devices Panel;

Gastroenterology and Urology Devices

Panel; General and Plastic Surgery

Devices Panel; General Hospital and

Personal Use Devices Panel; Hematology

and Pathology Devices Panel;

Immunology Devices Panel;

Microbiology Devices Panel;

Neurological Devices Panel; Obstetrics

and Gynecology Devices Panel;

Ophthalmic Devices Panel; Orthopedic

and Rehabilitation Devices Panel; and

the Radiological Devices Panel).

National Center for Toxicological

Research:

Science Advisory Board to the

National Center for Toxicological

Research.

FDA is also announcing the

availability of annual reports for the

following advisory committees during

the period October 1, 1995, through

September 30, 1996:

Center for Biologics Evaluation and

Research:

Allergenic Products Advisory

Committee,

Blood Products Advisory Committee,

Vaccines and Related Biological

Products Advisory Committee.

Center for Drug Evaluation and

Research:

Anesthetic and Life Support Drugs

Advisory Committee,

Antiviral Drugs Advisory Committee,

Endocrinologic and Metabolic Drugs

Advisory Committee,

Medical Imaging Drugs Advisory

Committee,

Oncologic Drugs Advisory Committee,

Pulmonary-Allergy Drugs Advisory

Committee.

Center for Devices and Radiological

Health:

Medical Devices Advisory Committee

(consisting of reports for the

Anesthesiology and Respiratory

Therapy Devices Panel; Circulatory

System Devices Panel; Clinical

Chemistry and Clinical Toxicology

Devices Panel; Dental Products Panel;

Ear, Nose, and Throat Devices Panel;

Gastroenterology and Urology Devices

Panel; General and Plastic Surgery

Devices Panel; General Hospital and

Personal Use Devices Panel; Hematology

and Pathology Devices Panel;

Immunology Devices Panel;

Microbiology Devices Panel;

Neurological Devices Panel; Obstetrics

and Gynecology Devices Panel;

Ophthalmic Devices Panel; Orthopedic

and Rehabilitation Devices Panel; and

the Radiological Devices Panel).

National Center for Toxicological

Research:

Science Advisory Board to the

National Center for Toxicological

Research.

FDA is also announcing the

availability of annual reports for the

following advisory committees during

the period October 1, 1996, through

September 30, 1997:

Center for Biologics Evaluation and

Research:

Allergenic Products Advisory

Committee,

Biological Response Modifiers

Advisory Committee,

Blood Products Advisory Committee,

Vaccines and Related Biological

Products Advisory Committee.

Center for Drug Evaluation and

Research:

Anesthetic and Life Support Drugs

Advisory Committee,

Anti-Infective Drugs Advisory

Committee,

Antiviral Drugs Advisory Committee,

Arthritis Advisory Committee,

Cardiovascular and Renal Drugs

Advisory Committee,

Drug Abuse Advisory Committee,

Dermatologic and Ophthalmic Drugs

Advisory Committee,

Endocrinologic and Metabolic Drugs

Advisory Committee,

Nonprescription Drugs Advisory

Committee.

Center for Devices and Radiological

Health:

Medical Devices Advisory Committee

(consisting of reports for the

Anesthesiology and Respiratory

Therapy Devices Panel; Circulatory

System Devices Panel; Clinical

Chemistry and Clinical Toxicology

Devices Panel; Ear, Nose and Throat

Devices Panel; Gastroenterology and

Urology Devices Panel; General and

Plastic Surgery Devices Panel; General

Hospital and Personal Use Devices

Panel; Hematology and Pathology

Devices Panel; Immunology Devices

Panel; Neurological Devices Panel;

Obstetrics and Gynecology Devices

Panel; Ophthalmic Devices Panel;

Orthopedic and Rehabilitation Devices

Panel; and Radiological Devices Panel).

National Center for Toxicological

Research:

Science Advisory Board to the

National Center for Toxicological

Research.

Annual reports are available for

public inspection at: (1) The Library of

Congress, Madison Bldg., Newspaper

and Current Periodical Reading Room,

101 Independence Ave. SE., rm. 133,

Washington, DC; and (2) the Dockets

Management Branch (address above),

between 9 a.m. and 4 p.m., Monday

through Friday.

Dated: June 29, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–18143 Filed 7–7–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0363]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

reinstatement of an existing collection

of information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

reporting and recordkeeping

requirements for new animal drugs for

investigational use.

DATES: Submit written comments on the

collection of information by September

8, 1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.
36922 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

reinstatement of an existing collection

of information, before submitting the

collection to OMB for approval. To

comply with this requirement, FDA is

publishing notice of the proposed

collection of information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

New Animal Drugs for Investigational

Use (21 CFR Part 511) (OMB Control

Number 0910–0117—Reinstatement)

FDA has the responsibility under the

Federal Food, Drug, and Cosmetic Act

(the act), for approval of new animal

drugs for investigational use. Section

512(j) of the act (21 U.S.C. 360b(j)),

requires that a sponsor submit to FDA

a ‘‘Notice of Claimed Investigational

Exemption’’ INAD, prior to shipment of

the new animal drug for clinical tests in

animals. The regulations implementing

statutory requirements for INAD

approval have been codified under part

511 (21 CFR part 511). The INAD

application must contain, among other

things, the following specific

information: (1) Identity of the new

animal drug; (2) labeling; (3) statement

of compliance of any nonclinical

laboratory studies with good laboratory

practices; and (4) name and address of

each clinical investigator and the

approximate number of animals to be

treated or amount of new animal drug(s)

to be shipped. Part 511 also requires

that records be established and

maintained to document the

distribution and use of the

investigational drug to assure that its

use is safe, that distribution is

controlled to prevent potential abuse,

and that edible products of treated

animals will not be distributed for food

without proper authorization from FDA.

The agency utilizes these required

records under its ‘‘Bio-Research

Monitoring Program’’ to monitor the

validity of the studies and to assure that

proper use of the drug is maintained by

the investigator.

Investigational new animal drugs are

sponsored primarily by drug industry

firms, academic institutions, and the

government. Investigators may include

individuals from these entities as well

as research firms and members of the

medical profession. Respondents to this

collection of information are both

sponsors and investigators.

FDA estimates the burden for this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

511.1(b)(4) 190 6 1,147 8 9,176

511.1(b)(5) 190 1.5 287 140 40,180

511.1(b)(6) 190 .005 1 250 250

511.1(b)(8)(ii) 190 .005 1 20 20

511.1 (b)(9) 190 .16 30 8 240

Total Burden Hours 49,866

1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

511.1(a)(3) 190 7.5 1,434 9 12,906

511.1(b)(3) 190 10 1,912 1 1,912

511.1(b)(7)(ii) 190 2 956 3.5 3,346

511.1(b)(8)(i) 190 4 956 3.5 3,346

Total Burden Hours 21,510

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimate of the time required for

reporting requirements, record

preparation, and maintenance for this

collection of information is based on

agency communication with industry.

Additional information needed to make

a final calculation of the total burden

hours (i.e., the number of respondents,

the number of recordkeepers, the

number of INAD applications received,

etc.) is derived from agency records.

Dated: June 30, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18145 Filed 7–7–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E–0308]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; IVOMEC EPRINEXTM

Pour-On for Beef and Dairy Cattle

AGENCY: Food and Drug Administration,

HHS.